Totema solution for oral administration in ampoules 10ml No. 20

Contraindications and indications for Totem from the instructions

The drug is prescribed to patients with pathologies identified by diagnostic examination:

• iron deficiency anemia – for patients older than 3 months;
• hypovitaminosis - for people at risk: blood donors, pregnant women, newborns (from mothers with documented iron deficiency).

Totem is contraindicated:

• in anemic conditions not associated with insufficient iron intake;
• exacerbation of gastrointestinal ulcers;
• thalassemia, hemochromatosis, hemosiderosis;
• poisoning with lead, manganese, copper;
• intolerance to the component composition;
• hepatolenticular degeneration, etc.

Increased caution is needed when treating patients with inflammatory processes in the small intestine, colon, diverticulitis, and granulomatous lesions of the gastrointestinal tract.

The medicine is approved for the treatment of pregnant women; it is contraindicated in breastfeeding due to the high probability of the active components passing into milk.

Totema solution for oral administration in ampoules 10ml No. 20

Name

Totema amp. 10ml No. 20

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Expiration date from date of manufacture

2 years

Product description

The solution for oral administration is dark brown in color, with a characteristic odor; There may be some slight sediment.

pharmachologic effect

Combined antianemic drug. Contains iron, which is necessary for the synthesis of heme, which is part of hemoglobin, myoglobin, flavoproteins, iron-ferritin and iron-transferrin complexes, various enzymes; participates in a number of redox reactions. Copper and manganese are microelements and are cofactors for some enzymes. The absorption of microelements is more intense, the greater the iron deficiency in the body. When taking the drug, there is a gradual regression of clinical and laboratory symptoms of anemia.

Pharmacokinetics

Pharmacokinetics Absorption of iron and other trace elements occurs predominantly in the duodenum and upper jejunum.

Indications for use

Treatment and prevention of iron deficiency anemia in adults and children from 3 months of age caused by various reasons:

• bleeding;
• increased need for iron (pregnancy);
• insufficient intake of iron from food or impaired absorption.

Use during pregnancy and lactation

The drug is allowed to be used during pregnancy and lactation according to indications in recommended doses.

special instructions

Monitoring the effectiveness of treatment should be carried out no earlier than 3 months after the start of treatment. Excessive tea consumption inhibits iron absorption. To avoid darkening of tooth enamel, prolonged exposure of the drug solution to the oral cavity should be avoided. Patients with diabetes should take into account that 10 ml of the drug contains 3 g of sucrose. 1 ampoule of the drug contains 1/4 XE, the maximum daily dose (in 4 ampoules of the drug) is 1 XE. During treatment with iron supplements, patients may experience black stool, however, this does not require medical intervention. During treatment with iron supplements, a stool occult blood test may give a false-positive result. Effect on the ability to drive vehicles and operate machinery There is no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.

With caution (Precautions)

The drug should be prescribed with caution for diabetes mellitus.

Contraindications

• anemia not associated with iron deficiency;
• hemochromatosis, hemosiderosis;
• thalassemia;
• peptic ulcer of the stomach and duodenum in the acute phase;
• lead intoxication;
• copper or manganese intoxication, Wilson-Konovalov disease;
• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption syndrome;
• children up to 3 months;
• hypersensitivity to the components of the drug.

Directions for use and doses

To treat anemia, adults are prescribed the drug at the rate of 100-200 mg of iron (2-4 amp.)/day; children over 3 months old - at the rate of 5-7 mg/kg body weight/day in 2-4 doses. The use of the drug is carried out under the control of the iron content in the blood serum, the total iron-binding capacity of the serum before the start of treatment and subsequently at intervals of 1 time in 2 months. For preventive purposes, adults and pregnant women (starting from the 4th month of pregnancy) are prescribed 50 mg (1 amp.)/day. For children, depending on age, the drug is prescribed in a dose ranging from 1/4 to 1/2 the daily therapeutic dose of adults. The duration of treatment is determined individually. The average duration of taking the drug is from 3 to 6 months (until the iron reserves in the body are restored). Instructions for using the drug: Shake well before use. You should tear off a piece of cardboard from the pack along the dotted line and bend it in half to safely break the tip of the ampoule. Break the ampoule on both sides, pour the contents of the ampoule into a glass, dissolve in plain or sweetened water. Take orally, before meals.

Overdose

Symptoms: weakness, hyperthermia, convulsions, nausea, vomiting, constipation, diarrhea, epigastric pain. Cases of necrosis of the walls of the gastrointestinal tract and shock have been described. Treatment: gastric lavage with 1% sodium bicarbonate solution (baking soda). When the concentration of iron in the blood serum is more than 5 mcg/ml, deferoxamine is administered intravenously slowly: for children - 15 mg/kg/h, for adults - 5 mg/kg/h (up to 80 mg/kg/day); for mild poisoning IM: children - 1 g every 4-6 hours, adults - 50 mg/kg (up to 4 g/day); carry out symptomatic therapy; If shock occurs, antishock therapy is carried out.

Side effect

From the digestive system: staining of stool black (this is normal), heartburn, nausea, vomiting, diarrhea, constipation, pain in the epigastric region, darkening of tooth enamel. Other: allergic reactions.

Compound

1 amp. iron (elemental, in the form of iron gluconate dihydrate) 50 mg manganese (elemental, in the form of manganese gluconate) 1.33 mg copper (elemental, in the form of copper gluconate) 700 mcg Excipients: glycerol - 2.52 g, dextrose (glucose) - 80 mg, sucrose - 3 g, anhydrous citric acid - 27.4 mg, sodium citrate dihydrate - 30 mg, sodium benzoate - 20 mg, polysorbate 80 - 24 mg, caramel color TPS (E150c) - 50 mg, tutti-frutti flavoring - 20 µl , purified water - up to 10 ml.

Interaction with other drugs

The simultaneous use of the drug Totema® leads to a decrease in the absorption of bisphosphonates, ciprofloxacin, and tetracyclines when taken orally. Salts, oxides and hydroxides of magnesium, aluminum and calcium interfere with the absorption of iron salts. Totema® should be taken no earlier than 2 hours after taking these medications. You cannot combine the drug with other iron preparations, incl. administered parenterally.

Release form

The solution for oral administration is dark brown in color, with a characteristic odor; There may be some slight sediment. 1 ml 1 amp. iron (elemental, in the form of iron gluconate dihydrate) 5 mg 50 mg manganese (elemental, in the form of manganese gluconate) 133 mcg 1.33 mg copper (elemental, in the form of copper gluconate) 70 mcg 700 mcg Excipients: glycerol - 2.52 g, dextrose ( glucose) - 80 mg, sucrose - 3 g, anhydrous citric acid - 27.4 mg, sodium citrate dihydrate - 30 mg, sodium benzoate - 20 mg, polysorbate 80 - 24 mg, caramel color TPS (E150c) - 50 mg, tutti flavoring -frutti" - 20 µl, purified water - up to 10 ml. 10 ml - double-ended ampoules made of yellow glass type III (10) - cardboard trays (2) - cardboard packs.

Features of therapy

The instructions recommend taking Totem before meals, dissolving the composition in drinking water and shaking it before use. The daily dosage is divided into 2-3 doses or used immediately:

• 3-12 months – 3 mg per kilogram of child’s weight;
• from 12 months to 5 years – 50 mg daily;
• from 5 to 12 years – from 1 to 2 ampoules every day;
• patients over 12 years of age - from 50 to 100 mg per day.

For moderate iron deficiency anemia - 3 ampoules per day, for severe form - 200 mg daily. For pregnant women, dosages change:

• mild iron deficiency - 2 ampoules;
• moderate - 150 mg;
• complex - 200 mg every day.

Nursing mothers are recommended to take 1 ampoule of the drug daily.

The duration of therapy is determined for each patient individually, based on the results of blood tests. Depending on the complexity of the anemia, treatment is carried out for up to 6 months in a row; pregnant women should take the medicine until the hemoglobin level normalizes. For preventive procedures, Totema is prescribed for a period of 1-2 months.

Totema 10ml 20 pcs. oral solution

pharmachologic effect

Iron preparation.

Composition and release form of Totem 10 ml 20 pcs. oral solution

Solution - 1 amp. (10 ml):

• Active ingredients: Iron gluconate dihydrate, amount corresponding to elemental iron - 50.00 mg; Manganese gluconate, amount corresponding to elemental manganese - 1.33 mg; Copper gluconate, amount corresponding to elemental copper - 0.70 mg;
• Excipients: glycerol, dextrose (glucose), sucrose, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, polysorbate 80, caramel color TPS (E150c), “Tutti-frutti” flavoring, purified water.

10 ml in two-ended ampoules made of yellow glass type III.

10 ampoules in cardboard pallets, 2 pallets with instructions for use in a cardboard box.

Description of the dosage form

Dark brown liquid with a characteristic odor. There may be some slight sediment.

Directions for use and doses

Inside, before meals. The contents of the ampoule are dissolved in plain or sweetened water. Shake before use.

Tear a piece of cardboard from the pack along the dotted line and bend it in half to safely break the ends of the ampoule. Break the ampoule on both sides, as shown in the figure, and pour the contents of the ampoule into a glass.

Doses

The daily dose can be divided into several doses or taken at a time. The daily dose of the drug depends on the degree of iron deficiency (see table of daily doses).

Daily doses of the drug Totema® for the prevention and treatment of iron deficiency anemia in adults and children from 3 months

Duration of use

The duration of use in children and adults is determined individually. During treatment, it is recommended to periodically determine the level of hemoglobin, ferritin, and serum iron in the blood.

The duration of treatment for IDA in children and adults can be up to 6 months, depending on the severity.

Treatment of IDA in pregnant women should be carried out until hemoglobin levels normalize. The duration of the course of prevention of iron deficiency, including in risk groups, can be 1-2 months.

Pharmacodynamics

Totema® is a combined antianemic drug containing divalent iron in the form of an organic salt of iron gluconate, as well as manganese gluconate and copper gluconate.

Iron, being part of numerous cellular structures and participating in the activity of many enzymatic systems (cytochromes, catalases), plays a very important role in oxygen transport and oxidative metabolic processes, and is also an important element of the human body, which is especially necessary for the formation of hemoglobin.

Pharmacokinetics

Suction

Iron is absorbed primarily in the duodenum and jejunum. Maximum absorption is observed when iron is taken on an empty stomach. Absorption varies and depends on body iron stores and physiological needs. In iron deficiency conditions, its absorption increases.

Distribution

After absorption, the bulk of the iron binds to transferrin and is transported to the bone marrow, where it is taken up by erythroid cells of the bone marrow for the synthesis of hemoglobin; the rest is contained in the blood and deposited in organs in the form of ferritin, hemosiderin, and myoglobin.

Removal

A small amount of iron is excreted from the body after the cyclic destruction of the hemoglobin molecule.

Indications for use of Totem 10ml 20 pcs. oral solution

Treatment of iron deficiency anemia (IDA) in adults and children from 3 months of age.

Prevention of iron deficiency in risk groups: during pregnancy, in children born from a mother with iron deficiency, in blood donors.

Contraindications

• Anemia not associated with iron deficiency;
• hemochromatosis, hemosiderosis;
• thalassemia;
• peptic ulcer of the stomach and duodenum in the acute stage;
• lead intoxication;
• hypersensitivity to the components of the drug;
• children up to 3 months;
• copper or manganese intoxication, Wilson-Konovalov disease;
• sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution: diabetes mellitus, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).

Application of Totem 10ml 20 pcs. solution for oral administration during pregnancy and lactation

Pregnancy

No negative effects of the drug on a pregnant woman, fetus or newborn have been identified, therefore, the drug can be used during pregnancy.

Breast-feeding

Due to the lack of data on the penetration of the drug into breast milk, women are advised to refrain from breastfeeding while taking the drug during lactation.

special instructions

This drug is not recommended for the treatment of hyposideremia (decreased serum iron levels) in inflammatory syndrome.

Taking iron supplements should, if possible, be carried out simultaneously with eliminating the causes of iron deficiency.

1 ampoule of the drug contains 1/4 of a bread unit, the maximum daily dose (in 4 ampoules of the drug) is 1 bread unit.

Patients with diabetes should take into account that 10 ml of the drug contains 3 g of sucrose and 0.08 g of glucose.

To avoid darkening of tooth enamel, the solution should be swallowed immediately and not retained in the oral cavity.

The drug Totema® contains a small amount of ethanol, less than 100 mg/1 ampoule.

During treatment with iron supplements, patients may experience black stool, however, this does not require medical intervention.

During treatment with iron supplements, a stool occult blood test may give a false-positive result.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.

Overdose

Overdose of iron salts

An overdose of iron salts is possible both with accidental intake of large doses of the drug, and with regular use in permitted doses, and is especially dangerous in children. Oral doses of iron of 20 mg/kg and above are considered toxic. An iron concentration in the blood serum of 5 mcg/ml or higher indicates severe poisoning with iron salts.

An iron dose of about 60 mg/kg is considered extremely dangerous for children. In children, intoxication with iron salts can lead to death if medical care is not provided in a timely manner.

In this regard, iron supplements should be stored out of the reach of children.

If you suspect an overdose of iron salts, you should immediately consult a doctor!

Immediate measures before providing medical attention: gastric lavage with clean water (you need to drink several glasses of water and induce vomiting).

Acute overdose

An acute overdose of iron salts can occur in several stages:

• Phase 1 of intoxication (the first 6 hours after an overdose): nausea, vomiting, diarrhea mixed with blood, abdominal pain, weakness, pale skin, cold sticky sweat, acidosis, weak pulse, decreased blood pressure, palpitations, depression of the central nervous system of various types degree of severity up to coma, convulsions.
• Phase 2 of intoxication (6-24 hours after an overdose): temporary stabilization of the condition.
• Phase 3 of intoxication (24-48 hours after overdose): renal and liver failure, jaundice, metabolic acidosis, collapse, fever, pulmonary edema, shock up to coma.
• Phase 4 of intoxication (several weeks after overdose): liver damage, intestinal obstruction.

Treatment

If an overdose of iron salts is suspected, treatment should be started immediately.

Children.

1. In the first hours after an overdose, vomiting should be induced.
2. Rinse the stomach. Laxatives should not be used in young children due to the risk of diarrhea. The patient requires constant monitoring; in case of possible aspiration of vomit, suction and oxygen may be needed. In case of more severe intoxication in children and the development of subsequent stages of poisoning, therapeutic measures should be carried out by a doctor.
3. The concentration of iron in the blood plasma should be constantly monitored.
4. In case of serious poisoning, in case of shock or coma with a high level of iron in the plasma, it is necessary to immediately provide assistance and begin administering a solution of a specific iron antidote - deferoxamine, according to the instructions for use of the drug. Shock, dehydration, and acid-base disorders should be treated with appropriate therapeutic methods.

Adults.

1. In the first hours after an overdose, vomiting should be induced.
2. Rinse the stomach. The patient requires constant monitoring; in case of possible aspiration of vomit, suction and oxygen may be needed. For faster bowel movements, it is possible to use an aqueous solution of mannitol and sorbitol.
3. The concentration of iron in the blood plasma should be constantly monitored.
4. In case of serious poisoning, in case of shock or coma with a high level of iron in the plasma, it is necessary to immediately provide assistance and begin administering a solution of a specific iron antidote - deferoxamine, according to the instructions for use of the drug. Shock, dehydration, and acid-base disorders should be treated with appropriate therapeutic methods.

Overdose of manganese salts

Symptoms: nausea, vomiting, diarrhea, decreased activity, muscle pain, lethargy, fatigue, drowsiness, headache, hallucinations, memory impairment, depression, impaired muscle tone, paresthesia, muscle atrophy, symptoms of parkinsonism.

Treatment: symptomatic therapy.

Overdose of copper salts

Symptoms: nausea, vomiting, diarrhea, abdominal pain, chest pain, metallic taste in the mouth, muscle pain, increased irritability, depression.

Treatment: gastric lavage, enterosorbents, diuretics and laxatives, symptomatic therapy.

Side effects of Totem 10ml 20 pcs. oral solution

The frequency of adverse reactions is presented as follows: very often (more than 1/10 cases), often (more than 1/100 and less than 1/10 cases), infrequently (more than 1/1000 and less than 1/100 cases), rarely (more than 1 /10000 and less than 1/1000 cases) and very rarely (less than 1/10000 cases). Adverse reactions, the frequency of which cannot be estimated from the available data, are designated “frequency unknown.”

Gastrointestinal disorders - Uncommon: nausea, vomiting, heartburn, constipation, diarrhea, epigastric pain, black stool (normal).

Immune system disorders - Frequency unknown: allergic reactions.

Other - Uncommon: discoloration of tooth enamel (occasional brown or black spots), reversible after completion of treatment.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Drug interactions

It is not recommended to combine the drug with iron preparations for parenteral administration. When used together, lipothymia (fainting reaction) or shock caused by the rapid release of iron from its complex compounds and saturation of siderophilin are possible.

Caution is required when combined with:

Tetracyclines; fluoroquinolones; bisphosphonates for oral use; penicillamine; thyroxine.

It is recommended to take these medications at least 2 hours before or 2 hours after taking an iron supplement, since their absorption is reduced when taking iron supplements.

Salts, oxides and hydroxides of calcium, magnesium and aluminum

It is recommended to take these medications at least 2 hours before or 2 hours after taking an iron supplement, since iron absorption is reduced when taking these medications.

Excessive tea consumption inhibits iron absorption.

Adverse reactions

The medication may cause the development of non-standard symptoms:

• dyspeptic disorders;
• allergic reactions - itching, redness, skin rashes;
• staining of teeth - with dark scattered spots.

Sometimes black stool is observed, which is normal and does not require stopping the medication. If any of these symptoms appear, the patient should visit a doctor and tell in detail about the changes that have occurred.

The nuances of overdose

The instructions for the drug draw attention to the following variants of hypervitaminosis:

1. Excess of iron salts

Exceeding the amount of a component is associated with accidental use of a large volume of medication or regular use of Totema in acceptable dosages. Complex intoxication with the drug is confirmed by the presence of 0.005 mg/l of the element in the bloodstream.

In childhood, poisoning with the component can cause death; a volume of 60 mg per kg is dangerous. Help consists of gastric lavage and the use of activated carbon - 1 tablet for every 10 kg of weight.

2. Excess of manganese salts

Poisoning is manifested by dyspeptic disorders and myalgia. Intoxication provokes problems with muscle tone, memory, causes depression, atrophic changes in muscles, and disturbances of consciousness. Overdose requires symptomatic treatment.

3. Excess copper salts

Intoxication leads to painful sensations in the abdomen, chest area, and muscles. Patients experience unreasonable irritability, a metallic taste in the mouth, and depression. Intoxication is treated by gastric lavage using diuretics, laxatives, and sorbents.

Features of interaction and manufacturer's instructions

The abstract points out the following nuances:

• Totema is not combined with drugs for parenteral administration that contain iron;
• combination with iron-containing medications can lead to fainting and shock;
• It is necessary to observe an interval of 120 minutes between taking the drug and tetracyclines, fluoroquinolones, thyroxine, penicillamine;
• If you drink too much, the rate of iron absorption slows down sharply.

When treating with Totema, you must adhere to the following instructions:

• the medication is not suitable for solving the problem of reduced levels of iron in the blood serum that occur with inflammatory pathologies;
• treatment of vitamin deficiency should be carried out together with the elimination of the sources that provoked it;
• When using the solution, it must be swallowed immediately to avoid darkening of the enamel.

Patients with diabetes mellitus should not forget that 50 ml of the product contains sucrose (3 g) with glucose (0.08 g) and a quarter of XE. Each ampoule of solution contains a small amount of ethanol.

The drug does not affect the reaction rate. During the procedures, patients can drive vehicles and work with complex moving mechanisms.

Tot'hema®

Overdose of iron salts

An overdose of iron salts is possible both with accidental intake of large doses of the drug, and with regular use in permitted doses, and is especially dangerous in children. Oral doses of iron of 20 mg/kg and above are considered toxic. An iron concentration in the blood serum of 5 mcg/ml or higher indicates severe poisoning with iron salts.

An iron dose of about 60 mg/kg is considered extremely dangerous for children. In children, intoxication with iron salts can lead to death if medical care is not provided in a timely manner.

In this regard, iron supplements should be stored out of the reach of children.

If you suspect an overdose of iron salts, you should immediately consult a doctor!

Immediate measures before providing medical attention: gastric lavage with clean water (you need to drink several glasses of water and induce vomiting).

Acute overdose

An acute overdose of iron salts can occur in several stages:

1st phase of intoxication

(first 6 hours after overdose): nausea, vomiting, diarrhea mixed with blood, abdominal pain, weakness, pale skin, cold sticky sweat, acidosis, weak pulse, decreased blood pressure, palpitations, depression of the central nervous system of varying degrees of severity up to to coma, convulsions.

Phase 2 of intoxication

(6-24 hours after overdose): temporary stabilization of the condition.

Phase 3 of intoxication

(24-48 hours after overdose): renal and liver failure, jaundice, metabolic acidosis, collapse, fever, pulmonary edema, shock up to coma.

4th phase of intoxication

(several weeks after overdose): liver damage, intestinal obstruction.

Treatment

If an overdose of iron salts is suspected, treatment should be started immediately.

Children

.

1. In the first hours after an overdose, vomiting should be induced.

2. Rinse the stomach. Laxatives should not be used in young children due to the risk of diarrhea. The patient requires constant monitoring; in case of possible aspiration of vomit, suction and oxygen may be needed. In case of more severe intoxication in children and the development of subsequent stages of poisoning, therapeutic measures should be carried out by a doctor.

3. The concentration of iron in the blood plasma should be constantly monitored.

4. In case of serious poisoning, in case of shock or coma with a high level of iron in the plasma, it is necessary to immediately provide assistance and begin the administration of a solution of a specific iron antidote - deferoxamine, according to the instructions for use of the drug. Shock, dehydration, and acid-base disorders should be treated with appropriate therapeutic methods.

Adults

.

1. In the first hours after an overdose, vomiting should be induced.

2. Rinse the stomach. The patient requires constant monitoring; in case of possible aspiration of vomit, suction and oxygen may be needed. For faster bowel movements, it is possible to use an aqueous solution of mannitol and sorbitol.

3. The concentration of iron in the blood plasma should be constantly monitored.

4. In case of serious poisoning, in case of shock or coma with a high level of iron in the plasma, it is necessary to immediately provide assistance and begin the administration of a solution of a specific iron antidote - deferoxamine, according to the instructions for use of the drug. Shock, dehydration, and acid-base disorders should be treated with appropriate therapeutic methods.

Overdose of manganese salts

Symptoms

: nausea, vomiting, diarrhea, decreased activity, muscle pain, lethargy, fatigue, drowsiness, headache, hallucinations, memory impairment, depression, impaired muscle tone, paresthesia, muscle atrophy, symptoms of parkinsonism.

Treatment

: symptomatic therapy.

Overdose of copper salts

Symptoms

: nausea, vomiting, diarrhea, abdominal pain, chest pain, metallic taste in the mouth, muscle pain, increased irritability, depression.

Treatment

: gastric lavage, enterosorbents, taking diuretics and laxatives, symptomatic therapy.